HomeChinaShenzhen IMDK Medical Technology Co.,Ltd.

Shenzhen IMDK Medical Technology Co.,Ltd.

China · 深圳 · imdkmedical.com
✓ Record-verifiedregistrations found in 8 marketsUnified social credit code 91440300MA5DEX6N0Q

This company holds 5 NMPA certificates in China and has registrations in United States, United Kingdom, Brazil, Canada, South Korea, Australia, Israel — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class II 5
as of 2026-09-04 · NMPA records sit under a different credit code (61242463) — possibly an affiliated entity
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
7listed device types
Class I 0Class II 7Class III 0
plus 8 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class IIa 3
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Business type not stated 1Import 1
AUAustraliaTGA ARTG
6active ARTG entries
IIa 5IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States8 registration records, 7 510(k), 0 PMA
China5 certificates (Class III 0 / II 5 / I 0), as of 2026-09-04
United Kingdom3 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

UK responsible person
Medimap Ltd
Unified social credit code
91440300MA5DEX6N0Q
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
48
Annual revenue
under RMB 5M
Website
imdkmedical.com
Product categories
呼吸、麻醉和急救器械妇产科、辅助生殖和避孕器械手术室及急救医用诊察和监护器械临床检验器械及试剂

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2016-06-20
Registered capital
CNY 5,000,000
Paid-in capital
CNY 3,740,000
Legal form
Limited liability company (wholly owned by a natural person)
Industry classification
Wholesale trade
Last approval date
2023-12-25
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative SME

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

22018 · K173123
12022 · K221979
22024 · K243118
22026 · K252655

FDA listed device types

Stimulator, Nerve, Transcutaneous, Over-The-Counter 1System, Measurement, Blood-Pressure, Non-Invasive 1Monitor, Ultrasonic, Fetal 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Blood Pressure Cuff 1Oximeter, Infrared, Sporting, Aviation 1Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20252081338压电网式雾化器Class II
CN粤械注准20252070408手腕式电子血压计Class II
CN粤械注准20252070289臂式电子血压计Class II
CN粤械注准20232072191指夹式脉搏血氧仪Class II
UK45607Pulse OximeterClass IIa
UK35457Portable Mesh NebulizerClass IIa
UK45617Spinegear Blood pressure monitor BPM- W1VL, BPM- A7VLClass IIa
USK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)2026-05-11
USK253133Wrist Blood Pressure Monitor (BPM-W1VL)2026-02-13
USK243118Arm Blood Pressure Monitor (model: BPM-A7VL)2024-11-26
BR80023149011INALADOR/NEBULIZADOR PORTÁTIL MESHClass II

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